BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASCAL SYNTHESIS 577NM

    MDR report key: 8021581 · Received October 30, 2018

    Report

    Report Number
    3008599994-2018-00001
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    October 25, 2018
    Report Date
    November 1, 2018
    Manufacturer
    TOPCON MEDICAL LASER SYSTEMS, INC.
    Product Code
    HQF
    PMA / PMN Number
    K123542
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CERTIFIED FIELD SERVICE ENGINEER FROM TOPCON MEDICAL LASER SYSTEMS, INC. VISITED THE SITE TO INVESTIGATE THE UNIT ON OCTOBER 29TH, 2018. NOTES FROM SITE VISIT: THE UNIT WAS FOUND TO BE WORKING WITHIN MANUFACTURER'S SPECIFICATIONS. AFTER DISCUSSION WITH THE PHYSICIAN- IT WAS CONFIRMED THAT THE PATIENT DID NOT COMPLAIN OF ANY PAIN AND DISCOMFORT AS A RESULT OF THIS INCIDENT. THE VISUAL ACUITY WAS REPORTED TO BE 'GOOD' POST-INCIDENT. A FOLLOW UP VISIT FOR THIS PATIENT IS SCHEDULED. IT HAS BEEN DETERMINED THAT THE PHYSICIAN NEEDS ADDITIONAL CLINICAL TRAINING FOR PASCAL SYNTHESIS, PARTICULARLY THE TITRATION FEATURE. THE PHYSICIAN DID NOT PERFORM TITRATION PRIOR TO INITIATING TREATMENT. THE SITE HAS BEEN ADVISED TO REFRAIN FROM USING THIS UNIT UNTIL THE ONSITE CLINICAL TRAINING IS COMPLETED. 'BRUCH'S MEMBRANE RUPTURE' IS A KNOWN SIDE EFFECT AND IS STATED IN THE OPERATOR MANUAL. CORRECTION IN SECTION TYPE OF REPORT. 5-DAY REPORT WAS INADVERTENTLY CHECKED.

    Description of Event or Problem · 0

    RECEIVED A CALL FROM THE PHYSICIAN STATING THAT HE POPPED BRUCH'S MEMBRANE WHILE PERFORMING LASER ON A PATIENT ON (B)(6) 2018. HE WAS IN THE MIDDLE OF A SINGLE-SPOT PRP PAST THE EQUATOR. HE WAS USING 200 MICRON SPOT SIZE AT 200 MW OF POWER.

    Additional Manufacturer Narrative · 1

    A CERTIFIED FIELD SERVICE ENGINEER FROM TOPCON MEDICAL LASER SYSTEMS, INC. VISITED THE SITE TO INVESTIGATE THE UNIT ON (B)(6) 2018. NOTES FROM SITE VISIT: THE UNIT WAS FOUND TO BE WORKING WITHIN MANUFACTURER'S SPECIFICATIONS. AFTER DISCUSSION WITH THE PHYSICIAN- IT WAS CONFIRMED THAT THE PATIENT DID NOT COMPLAIN OF ANY PAIN AND DISCOMFORT AS A RESULT OF THIS INCIDENT. THE VISUAL ACUITY WAS REPORTED TO BE 'GOOD' POST-INCIDENT. A FOLLOW UP VISIT FOR THIS PATIENT IS SCHEDULED. IT HAS BEEN DETERMINED THAT THE PHYSICIAN NEEDS ADDITIONAL CLINICAL TRAINING FOR PASCAL SYNTHESIS, PARTICULARLY THE TITRATION FEATURE. THE PHYSICIAN DID NOT PERFORM TITRATION PRIOR TO INITIATING TREATMENT. THE SITE HAS BEEN ADVISED TO REFRAIN FROM USING THIS UNIT UNTIL THE ONSITE CLINICAL TRAINING IS COMPLETED. 'BRUCH'S MEMBRANE RUPTURE' IS A KNOWN SIDE EFFECT AND IS STATED IN THE OPERATOR MANUAL.

    Description of Event or Problem · 1

    RECEIVED A CALL FROM THE PHYSICIAN STATING THAT HE POPPED BRUCH'S MEMBRANE WHILE PERFORMING LASER ON A PATIENT ON (B)(6) 2018. HE WAS IN THE MIDDLE OF A SINGLE-SPOT PRP PAST THE EQUATOR. HE WAS USING 200 MICRON SPOT SIZE AT 200 MW OF POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861718 PASCAL SYNTHESIS 577NM OPHTHALMIC SCANNING LASER SYSTEM, HQF TOPCON MEDICAL LASER SYSTEMS, INC. SA-06285

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other